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  In this post, PATH Vice President of Product Development, David Kaslow, writes about the first-ever shipment of semisynthetic artemisinin (ssART)—a new type of malaria treatment that marks a significant milestone in the fight against malaria. This post originally appeared on the PATH blog on August 12. Malaria drugs made with semisynthetic artemisinin make their way to patients This month, after nearly ten years of effort, the first batch of malaria drugs manufactured with a new, semisynthetic form of the key ingredient, artemisinin, will start reaching African countries battling the disease. The lifesaving drugs, manufactured by our partner Sanofi, a French pharmaceutical company, are the first of their kind to use ssART in place of the plant-derived form of artemisinin used in the past. The new shipment marks a milestone in global health, potentially improving access to treatment for the millions of people, mostly African children, sickened by malaria every year. The story of ssART—and the bold partnership that brought it from concept to use—highlights the crucial role international markets play in shaping global health, and the power of collaborative innovation to improve the systems that bring lifesaving products to the people who need them. Soothing a volatile market The first batch of malaria drugs manufactured with a new, semisynthetic form of the key ingredient, artemisinin, will start reaching African countries battling the disease. Photo: PATH In 2004, doctors worldwide were increasingly using a powerful group of drugs called artemisinin-based combination therapies (ACTs), to treat malaria infection. That was good news for children and families everywhere. But as more countries sought ACTs, the supply and price of artemisinin—which was derived only from a slow-growing plant called Artemisia annua, or Asian sweet wormwood—fluctuated wildly. Changes in demand and supply from year to year created a volatile up-and-down cycle of pricing and supply. In 2005, for example, the price of artemisinin was at a high of US$1,100 per kilogram. That price sparked more farmers to plant sweet wormwood, creating an oversupply in 2007 that caused the price to plummet to just $180 per kilogram. That cut the incentive to grow sweet wormwood again, which resulted in a 2009 shortage that drove prices back up over the next two years, to an average of $530 per kilogram in 2011. These fluctuations strained markets, and made it difficult for leaders, manufacturers, and others to stabilize and plan global supply, risking a global shortage. In short, the lifesaving drugs that millions of children, families, and communities relied upon were tied to a supply structure struggling under the push and pull of a volatile market. Worldwide, a market challenge had turned into a crucial global health imperative.   A groundbreaking partnership Solving the challenge took a groundbreaking partnership, led by PATH’s Drug Development program, which brought together experts in research, pharmaceutical product development, and public health. In 2004, the partnership set out to develop a new manufacturing process to produce high-quality, year-round, and affordable artemisinin to supplement the plant-based supply. Over a decade of work, our combined innovation and vision brought a promising concept from small laboratory batches, to large-scale production, and on to global markets. Now, as the first shipment of ssART-based malaria drugs—1.7 million treatments of Sanofi’s gold-standard ACT, Artesunate Amodiaquine Winthrop®—make their way to customers for the first time, we’ve reached the goal we set out to achieve ten years ago. Semisynthetic artemisinin opens a new future for the global artemisinin market. In doing so, it offers new security for the millions of people who rely on ACTs in countries where malaria is a constant threat. By providing a year-round source, ssART helps to manage imbalances in supply and demand, maintain stable and affordable pricing, and keep the market on an even course—ultimately expanding access to ACTs. The future Over a decade of work, PATH's combined innovation and vision brought a promising concept from small laboratory batches, to large-scale production, and on to global markets. Photo: PATH Of course, ssART is only one part of the solution. Eliminating and controlling malaria requires a highly integrated strategy, including new vaccines and diagnostics, expanded surveillance and control, strong partnerships with governments, and much more. I think I can speak for all of our partners when I say that we won’t be satisfied until that very last patient is cured of malaria. Until then, however, the sustained production of ssART, and the careful integration of our product into global markets, has the potential to change the landscape of global health. For the first time in history, artemisinin shouldn’t be a limiting factor in our work to develop and deploy lifesaving treatments. Even more, ssART provides clear evidence that with expertise, hope, and tenacity, it is possible for public and private sector leaders to achieve a bold humanitarian goal. Together, we’re paving the way for a robust, reliable supply of antimalarial drugs. And by continuing to work together, we can create a market where supply chains, farmers, extractors, manufacturers, and funders all align to create a healthier future for women and children worldwide. More Information About the semisynthetic artemisinin project Video: Steve Davis discusses this shared value partnership

The African Leaders Summit highlighted several initiatives to stimulate innovation. Photo: PATH/Gabe BienczyckAs the first-ever US-Africa Leaders Summit came to a close last week, it was clear that the energy around the partnerships between the United States and African nations are strong and building momentum. This was perhaps best exemplified by the enthusiasm in the room as President Obama and the First Lady spoke to a large crowd at the Young Africans Leadership Initiative symposium—an event that illustrated the Summit’s theme of ‘Investing in the Next Generation.’ Forty-five African heads of state gathered with US government officials and advocates to forge a path forward for partnership between the United States and African nations. Importantly, amid these discussions were several calls for initiatives to stimulate science, technology, and innovation as a way to harness African nations’ growing interest and capacity for locally-driven solutions.The summit was a busy few days with a flurry of announcements. We’ve seen over $37 billion in commitments announced by the US government and various stakeholders, including several targeting health issues like malaria, preventable childhood death, and reproductive, maternal, and newborn health. But beyond the state dinners and the official speeches—and the huge array of side events and discussions—what does the Summit really mean for global health innovation? What will its practical impact be? Here are four key takeaways:1. There is a paradigm shift taking place from traditional forms of aid to new multi-sectoral partnerships for developmentAs major US bilateral global health and development programs have shifted (as others have noted) from providing emergency relief toward more sustainable development models based on trade partnerships and private sector investment, support for science and innovation infrastructure and programming is evolving as well. There is growing recognition that new health technologies no longer emerge from one country’s labs or a handful of Western research institutes, but instead from all corners of the globe. This new paradigm was robustly reflected throughout the Summit.2. The United States is ready to shake up the status quo to support innovationAt several Summit events such as the National Academy of Sciences (NAS)-hosted symposium on Innovation and Impact, it was clear just how global the innovation ecosystem has become. National academies for science and technology and new public-private partnerships are growing capacity for innovation and product development in countries that previously had little or none. It is essential to ensure that new tools are acceptable and accessible to the populations that need them and that local research and innovation efforts are supported. Our global system of funding, introducing, and scaling new health tools must adapt to make this a reality. There are signs that the US government recognizes this shift and is ready to explore new ways of promoting innovation—such as leveraging the new US Agency for International Development (USAID) Global Development Lab to support new models of collaboration. Dr. Lona Stoll—director of the Center of Global Solutions at the Lab—called on participants to partner in breaking down barriers to innovation, and to this aim, USAID announced last week that it will be contributing $1.5 million to the World Bank’s regulatory harmonization trust fund to support regulatory harmonization efforts in Africa—a notable start.3. The world is watching: Will these commitments have teeth?The exciting commitments and pledges lauded at the Summit must be more than just words. While many funding and technical assistance commitments were made, in the next few months we’ll see if the United States and its allies in the private sector and other sovereign states fulfill their promises. Many across the health, science, and development sectors are wondering how pledges made this month will be tracked and reported on. In order to bolster global health research and development partnerships with African states, commitments made last week must also be carried forth to other global discussions—such as those around the post-2015 sustainable development goals—in order to maximize their impact.4. To fight threats to health in Africa and elsewhere, we need to act nowAs the White House outlined, in our increasingly interconnected world, the US government needs a coordinated, proactive global health approach that brings the full force of US expertise in research, and innovation to the global fight against disease. There is no example as prescient as the current Ebola outbreak in Western Africa to illustrate the urgent need for strong US government support for an adaptive global health system and investment in new vaccines, drugs, diagnostics, and other global health tools.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. This month at the Saving Lives at Birth: A Grand Challenge for Development’s DevelopmentXChange event in Washington, DC, bright minds from all over the world came together to display groundbreaking prevention and treatment approaches for pregnant women and newborns in low- and middle-income countries. The event also offered an opportunity for policymakers and decision makers to talk about the importance of science, research, and innovation for global health. During last week’s US-Africa Leaders Summit, the White House released a fact sheet on American and African cooperation for global health. As the world’s largest donor to global health, the United States is committed to working with African governments to improve the health of its citizens—including achieving an AIDS-free generation, ending preventable maternal and child deaths, enhancing global health security, and supporting African countries invest in the health of its own citizens. The World Health Organization said it thinks an Ebola vaccine should be ready for public use by 2015. There is currently no vaccine or cure for Ebola, which is currently widespread in parts of West Africa and has killed over 900 people since March of this year. This year’s outbreak is the biggest ever reported since Ebola was discovered over 40 years ago. In the Huffington Post’s blog, Dr. Jonathan Mermin—director of the Center for Disease Control and Prevention’s National Center for HIV and AIDS, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis (TB) Prevention—writes about the desperate need for new tools to prevent, detect, and treat TB and that “until we have better ways of detecting and treating TB, thousands of Americans and millions of people worldwide will continue to suffer from an illness that should have been consigned to history long ago.” An experimental vaccine to prevent dengue could be commercially available by July 2015, according to the vaccine’s makers—pharmaceutical company Sanofi Pasteur. There is currently no vaccine to prevent this mosquito-borne disease that affects thousands of people—mainly in low- and middle-income countries—every year.

“Innovation can’t take place if people say we don’t need new tools,” said Partners in Health Co-founder Paul Farmer at an event sponsored by the Saving Lives at Birth: A Grand Challenge for Development program last week in Washington, DC. And new tools were certainly on display at DevelopmentXChange 2014—a key component of the Saving Lives at Birth program. The DevelopmentXChange is an opportunity for hundreds of bright minds to come together and display groundbreaking prevention and treatment approaches for pregnant women and newborns in low- and middle-income countries. The event is also a time for key policymakers and decision makers to talk about the importance of science, research, and innovation for global health. Saving Lives at Birth—a partnership between the US Agency for International Development (USAID), the Bill & Melinda Gates Foundation, the Government of Norway, Grand Challenges Canada, and the UK Department for International Development—provides funding for a select group of finalists that offer the most innovative new tools. Large crowds were spotted at the DevelopmentXChange Marketplace the morning of the event. The DevelopmentXChange opened up with a marketplace where finalists of the Saving Lives at Birth challenge could display their innovations and demonstrate how these new tools could make a difference in the lives of mothers and children in low-resourced settings. Imagine a giant science fair where, instead of competing for a blue ribbon, the participants are competing for funding to make their innovation a reality. On display were several proposed innovations from GHTC members FHI 360, Jhpiego, and PATH. FHI 360 proposed a synchronized schedule for postpartum women to receive family planning services and for their newborns to receive immunizations and growth monitoring all at the same time. One of the innovations Jhpiego developed was the E-Partogram—an affordable, easy-to-use handheld electronic decision-making tool for preventing and managing complications during labor. PATH was one of many other organizations to address postpartum hemorrhage by developing heat-stabilized oxytocin—a common treatment for hemorrhaging women after childbirth—in a fast-dissolving oral tablet that would treat postpartum hemorrhage.   USAID Administrator Raj Shah addresses the crowd at the DevelopmentXChange Forum After the marketplace, policymakers, scientists, members of the global health community, and the Saving Lives at Birth finalists gathered together for the DevelopmentXChange Forum, which included opening remarks from USAID Deputy Assistant Administrator for Global Health Katie Taylor, USAID Administrator Raj Shah, and Paul Farmer. Administrator Shah commended many of the past year’s innovations for making a real difference in the lives of women and children, and commented on how the Saving Lives at Birth program influenced the creation of USAID’s new Global Development Lab. The rest of the forum featured innovators from all over the world, including past Saving Lives at Birth challenge winners. One of the innovations featured at the forum was a new, low-cost device that assists in delivering babies when complications occur in the second stage of labor. The device—called the Odon Device—was originally thought of by an Argentine mechanic named Jorge Odon when he was thinking about how to get a cork out of a bottle one night. The Odon device is made of a film-like polyethylene material and could be a safer and easier way to deliver complicated births rather than using than forceps or a vacuum extractor. After Mr. Odon partnered with Becton, Dickinson and Company, and received funding from Saving Lives at Birth at last year’s DevelopmentXChange, the Odon Device was finally ready for full development. Now the device is being tested in clinical trials and—if approved—has the potential for wide application in resource poor settings. If there was one thing very apparent during the day, it was that great, life-saving ideas can come from anyone—no matter what they do or where they live. Saving Lives at Birth is a good example of a mechanism that brings governments, foundations, and for-profit companies together to encourage creativity and innovation to tackle some of the world’s most pressing problems. The day concluded with Wendy Taylor—director of USAID’s Center for Accelerating Innovation and Impact—announcing the winners of the Saving Lives at Birth challenge. GHTC members PATH and FHI 360 both won seed grants to get their ideas up and running so that one day they could have the potential to protect and improve the lives of mothers and children all over the world. GHTC congratulates all of the challenge winners and is inspired by every single one of the innovators who were at this year’s DevelopmentXChange.